“A COMPARATIVE CLINICAL STUDY OF YASHTIMADHU GHRITA AND LIGNOCAINE-NIFEDIPINE OINTMENT IN THE MANAGEMENT OF PARIKARTIKA (ACUTE FISSURE- IN- ANO).â€
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ASSESSMENT WILL BE DONE ON THE BASIS OF SPECIALLY PREPARED PERFORMA FOR ASSESSING RELIEF IN SIGN AND SYMPTOMS BY SCORING PATTERN
研究概览
简要总结
This study is open label comparative clinical study of local application of yashtimadhu ghrita and lignocaine-nifedipine in the management of parikartika (acute fissure in ano)
Routine blood investigations will be performed to rule out others .
special scoring scale has been prepared based on information in
ayurvedic classical texts which will be utilized for assessment and evaluation
METHOD:
· Grouping of Patients :
The patients shall be randomly allocated into two groups A & B, having minimum 15 patients in each group.
Group-A: Local application of Yashthimadhu Ghrita in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks.
Group-B: Local application of Lignocaine-nifedipine ointment in fissure bed Parikartika twice a day after sitz bath for 4 weeks.
· Common Treatment for both groups:
1. Warm water sitz bath with Panchavalkal Kwath, twice a day.
2. Erandbhrist Haritaki Churna 5gms HS (at bed time) with luke warm water.
· Procurement of trial drugs
Yashtimadhu ghritwill be procured from pharmacy of Gujrat Ayurved University, Jamnagar.
Lignocaine-nifedipine ointment (anobliss or any branded ointment) will be procured from local market.
· Duration of treatment
Four weeks
· Follow-up Period: One month
· Laboratory Investigation:
a. CBC
b. RBS,
c. Blood urea, Sr. Creatinine, Sr. Billirubin.
e. HIV, VDRL, HBsAg
f. Urine analysis- Routine & Microscopic
g. Stool examination- Routine & Microscopic
· Other Investigation:
Chest X-Ray, ECG, USG Abdomen, Colonoscopy if required.
OVERALL ASSESSMENT CRITERIA:
Patients will be assessed as per following gradation:
-
Complete remission: 100 % improvement in subjective and objective parameter
-
Marked improvement: 76 – 99 % relief in subjective and objective parameter
-
Moderate improvement: 51 - 75 % relief in subjective and objective parameter
-
Mild improvement: 26 - 50 % relief in subjective and objective parameter
-
Unchanged: Less than 25 % relief in subjective and objective parameter
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 17.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of Parikartika (Acute fissure-in-ano) having duration less than 12 weeks.
- •2.Controlled cases of Diabetese mallitus or Hypertension.
排除标准
- •1.Fissure-in-ano having duration- more than 12 weeks.
- •2.Patient below 17 & above 70 years of age.
- •3.Patient suffering from malignancy.
- •4.Patient suffering from HIV, VDRL, Hepatitis-B, T.B. 5.Fissure-in-ano associated with piles & fistula.
- •6.Multiple fissure in ano 7.Uncontrolled cases of Diabetes Mellitus and Hypertension.
结局指标
主要结局
ASSESSMENT WILL BE DONE ON THE BASIS OF SPECIALLY PREPARED PERFORMA FOR ASSESSING RELIEF IN SIGN AND SYMPTOMS BY SCORING PATTERN
时间窗: ASSESSMENT WILL BE DONE ON THE BASIS OF SPECIALLY PREPARED PERFORMA FOR ASSESSING RELIEF IN SIGN AND SYMPTOMS BY SCORING PATTERN
次要结局
- 1 MONTH(1 MONTH)